In April 2025, the U.S. Food and Drug Administration (FDA) issued a public alert concerning compounded topical finasteride products, commonly used to treat hair loss. While oral finasteride (marketed as Propecia and Proscar) is FDA-approved, its topical counterparts are not. The agency has received reports of adverse events associated with these unapproved topical formulations, prompting this warning.​

Understanding Finasteride

Finasteride is a 5-alpha-reductase inhibitor that reduces dihydrotestosterone (DHT) levels, a hormone linked to hair loss and benign prostatic hyperplasia (BPH). The FDA has approved oral finasteride for treating male pattern baldness and BPH. However, no topical finasteride products have received FDA approval.​

Reported Adverse Events

Between 2019 and 2024, the FDA received 32 reports of adverse events related to compounded topical finasteride. These events include:​

  • Erectile dysfunction

  • Decreased libido

  • Anxiety and depression

  • Suicidal ideation

  • Fatigue and insomnia

  • Testicular pain

  • Cognitive issues such as “brain fog”​

Notably, many individuals reported that these side effects persisted even after discontinuing the topical treatment. ​

Additional Risks

Topical finasteride formulations may also pose other risks:​

  • Local skin reactions: Irritation, redness, dryness, scaling, stinging, and burning sensations have been reported.

  • Unintentional exposure: The topical nature of the product increases the risk of transferring the medication to others through skin contact.

  • Risks to pregnant women: Finasteride is contraindicated during pregnancy due to the potential for birth defects in male fetuses. Unlike coated oral tablets, topical formulations lack protective barriers, increasing the risk of absorption through the skin. ​

FDA Recommendations

The FDA advises:

  • Healthcare providers: Inform patients about the potential risks associated with compounded topical finasteride, including the possibility of systemic side effects and unintentional exposure to others.

  • Consumers: Discuss the risks and benefits of using compounded topical finasteride with a qualified healthcare provider before initiating treatment.

  • Reporting adverse events: Report any side effects or quality issues to the FDA’s MedWatch Adverse Event Reporting program. ​

FDA-Approved Alternatives for Hair Loss Treatment

Given the risks associated with unapproved topical finasteride, individuals seeking treatment for hair loss should consider FDA-approved alternatives:

1. Oral Finasteride (Propecia)

  • Mechanism: Inhibits the conversion of testosterone to DHT, slowing hair loss.

  • Usage: 1 mg daily for male pattern baldness.

  • Considerations: Potential side effects include sexual dysfunction and mood changes. Not approved for use in women.​

2. Topical Minoxidil (Rogaine)

  • Mechanism: Vasodilator that increases blood flow to hair follicles, promoting growth.

  • Usage: Applied twice daily; available in 2% and 5% concentrations.

  • Considerations: Side effects may include scalp irritation and unwanted facial hair growth.​

3. Low-Level Laser Therapy (LLLT)

  • Mechanism: Uses red light to stimulate hair follicles and increase hair density.

  • Devices: FDA-cleared options include laser combs, caps, and helmets.

  • Considerations: Generally safe with minimal side effects; requires consistent use over several months for noticeable results. ​

While compounded topical finasteride is marketed as a treatment for hair loss, it lacks FDA approval and has been associated with significant adverse effects. Both healthcare providers and consumers should exercise caution and thoroughly evaluate the risks before considering its use.​

For more information and to report adverse events, visit the FDA’s MedWatch program.

This article is intended for informational purposes and should not replace professional medical advice. Always consult with a healthcare provider for medical guidance.